Table 4 Summary of safety during 24-week double-blind, randomised controlled trial (ADEPT) and throughout 2 years of open-label adalimumab exposure
AE24-Week randomised, controlled trial2 Years of adalimumab exposure
PlaceboAdalimumab
(N  =  162) n (%)(PY 71.1) Events (events/100 PY)(N  =  151) n (%)(PY 66.8) Events (events/100 PY)(N  =  298) n (%)(PY 676.5) Events (events/100 PY)
Any AE130 (80.2)487 (684.8)122 (80.8)430 (644.1)273 (91.6)1977 (292.2)
Any AE at least possibly related to study drug47 (29.0)138 (194.0)64 (42.4)156 (233.7)160 (53.7)556 (82.2)
Any severe AE11 (6.8)13 (18.3)5 (3.3)5 (7.5)54 (18.1)71 (10.5)
Any serious AE7 (4.3)11 (15.5)5 (3.3)5 (7.5)50 (16.8)62 (9.2)
Any AE leading to discontinuation of study drug5 (3.1)6 (8.4)6 (4.0)6 (9.0)20 (6.7)22 (3.3)
Infections64 (39.5)109 (153.3)68 (45.0)88 (131.8)207 (69.5)521 (77.0)
    Serious infections1 (0.6)1 (1.4)1 (0.7)1 (1.5)15 (5.0)16 (2.4)
Malignancies0 (0.0)0 (0.0)0 (0.0)0 (0.0)4 (1.3)4 (0.6)
    Lymphoma0 (0.0)0 (0.0)0 (0.0)0 (0.0)1 (0.3)1 (0.1)
    Non-melanoma skin cancers0 (0.0)0 (0.0)0 (0.0)0 (0.0)2 (0.7)2 (0.3)
    Other malignancies0 (0.0)0 (0.0)0 (0.0)0 (0.0)1 (0.3)1 (0.1)
Demyelinating disease0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Injection-site reaction5 (3.1)36 (50.6)10 (6.6)39 (58.4)43 (14.4)221 (32.7)
Opportunistic infection excluding tuberculosis*0 (0.0)0 (0.0)0 (0.0)0 (0.0)4 (1.3)4 (0.6)
Tuberculosis (peritoneal)0 (0.0)0 (0.0)0 (0.0)0 (0.0)1 (0.3)1 (0.1)
Lupus and lupus-like syndrome0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Congestive heart failure0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Death†0 (0.0)0 (0.0)0 (0.0)0 (0.0)3 (1.0)3 (0.4)

  • *All four patients had oral candidiasis.

  • †One death occurred outside of the adverse event (AE) reporting period that extends 70 days (equivalent to five adalimumab half-lives) beyond the last adalimumab injection.

  • ADEPT, Adalimumab Effectiveness in Psoriatic Arthritis Trial; PY, patient-years.